1.Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅳ): classification of hygroscopicity behaviors of capsules.
Yu LIN ; Huan-Zheng LI ; Zi-Chen LIANG ; Fang-Fang XU ; Xin ZHANG ; Zhen-Zhong WANG ; Bing XU ; Wei XIAO
China Journal of Chinese Materia Medica 2023;48(15):3997-4006
Hard capsules of traditional Chinese medicine(TCM) have different degrees of hygroscopicity, which affects the stability and efficacy of drugs. In this paper, 30 kinds of commercially available TCM capsules were used as the research object. The hygroscopicity curves of capsule contents, capsule shells, and capsules were tested respectively, and the first-order kinetic equation was used for fitting. The results show that during the 24 h hygroscopicity process, the capsule shell can reduce the weight gain caused by the hygroscopicity of the contents by 0.80%-53.0% and the hygroscopicity rate of the capsule contents by 1.74%-91.3%, indicating that the capsule shell has a strong delay effect on the hygroscopicity of the contents of the TCM capsules. Seven physical parameters of the contents of 30 kinds of TCM capsules were determined, and 14 prescription process-related parameters were sorted out. A partial least squares model for predicting the hygroscopicity rate of the contents of TCM capsules(with shell) for 24 h was established. It is found that the hygroscopicity rate of the capsule shell is positively correlated with the hygroscopicity of the contents of TCM capsules(with shell), suggesting that the capsule shell with a low hygroscopicity rate is helpful for moisture prevention. In addition, the pre-treatment process route of the preparation and the type of molding raw materials affect the hygroscopicity. A larger proportion of the extract in the capsule content and a smaller proportion of the fine powder of the decoction pieces indicate stronger hygroscopicity of the capsule content. The 24 h hygroscopicity rate of 15% was used as the classification node of hygroscopicity strength, and the hygroscopicity rate constant of 0.58 was used as the classification node of hygroscopicity speed. The classification system of hygroscopicity behaviors of TCM capsules was established: the varieties with strong and fast hygroscopicity accounted for about 6.67%, while those with strong and slow hygroscopicity accounted for about 33.3%; the varieties with weak and fast hygroscopicity accounted for about 26.7%, while those with weak and slow hygroscopicity accounted for about 33.3%. The classification system is helpful to quantify and compare the hygroscopicity behavior of different TCM capsules and provides a reference for the quality improvement, moisture prevention technologies, and material research of TCM capsules.
Medicine, Chinese Traditional
;
Wettability
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Capsules
;
Powders
;
Technology
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Drugs, Chinese Herbal
2.Discrete element simulation study of mixing process of Guizhi Fuling Capsules: parameter calibration.
Huan-Zheng LI ; Xue-Fang TANG ; Yu LIN ; Fang-Fang XU ; Xin ZHANG ; Hui-Qing YE ; Wei XIAO ; Zhen-Zhong WANG ; Bing XU
China Journal of Chinese Materia Medica 2023;48(15):4007-4014
The mixing process is a critical link in the formation of oral solid preparations of traditional Chinese medicine. This paper took the extract powder of Guizhi Fuling Capsules and Paeonol powder as research objects. The angle of repose, loose packing density, and particle size of the two powders were measured to calibrate discrete element simulation parameters for the mixing process. The discrete element method was used to calibrate the simulated solid density of Paeonol powder and extract powder of Guizhi Fuling Capsules based on the Hertz-Mindlin with JKR V2 contact model and particle scaling. The Plackett-Burman experimental design was used to screen out the critical contact parameters that had a significant effect on the simulation of the angle of repose. The regression model between the critical contact parameters and the simulated angle of repose was established by the Box-Behnken experimental design, and the critical contact parameters of each powder were optimized based on the regression model. The best combination of critical contact parameters of the extract powder of Guizhi Fuling Capsules was found to be 0.51 for particle-particle static friction coefficient, 0.31 for particle-particle rolling friction coefficient, and 0.64 for particle-stainless steel static friction coefficient. For Paeonol powder, the best combination of critical contact parameters was 0.4 for particle-particle static friction coefficient and 0.19 for particle-particle rolling friction coefficient. The best combination of contact parameters between Paeonol powder and extract powder of Guizhi Fuling Capsules was 0.27 for collision recovery coefficient, 0.49 for static friction coefficient, and 0.38 for rolling friction coefficient. The verification results show that the relative error between the simulated value and the measured value of the angle of repose of the two single powders is less than 1%, while the relative error between the simulated value and the measured value of the angle of repose of the mixed powder with a mass ratio of 1∶1 is less than 4%. These research results provide reliable physical property simulation data for the mixed simulation experiment of extract powder of Guizhi Fuling Capsules and Paeonol powder.
Wolfiporia
;
Calibration
;
Powders
;
Medicine, Chinese Traditional
;
Capsules
3.A multicenter epidemiological study of acute bacterial meningitis in children.
Cai Yun WANG ; Hong Mei XU ; Jiao TIAN ; Si Qi HONG ; Gang LIU ; Si Xuan WANG ; Feng GAO ; Jing LIU ; Fu Rong LIU ; Hui YU ; Xia WU ; Bi Quan CHEN ; Fang Fang SHEN ; Guo ZHENG ; Jie YU ; Min SHU ; Lu LIU ; Li Jun DU ; Pei LI ; Zhi Wei XU ; Meng Quan ZHU ; Li Su HUANG ; He Yu HUANG ; Hai Bo LI ; Yuan Yuan HUANG ; Dong WANG ; Fang WU ; Song Ting BAI ; Jing Jing TANG ; Qing Wen SHAN ; Lian Cheng LAN ; Chun Hui ZHU ; Yan XIONG ; Jian Mei TIAN ; Jia Hui WU ; Jian Hua HAO ; Hui Ya ZHAO ; Ai Wei LIN ; Shuang Shuang SONG ; Dao Jiong LIN ; Qiong Hua ZHOU ; Yu Ping GUO ; Jin Zhun WU ; Xiao Qing YANG ; Xin Hua ZHANG ; Ying GUO ; Qing CAO ; Li Juan LUO ; Zhong Bin TAO ; Wen Kai YANG ; Yong Kang ZHOU ; Yuan CHEN ; Li Jie FENG ; Guo Long ZHU ; Yan Hong ZHANG ; Ping XUE ; Xiao Qin LI ; Zheng Zhen TANG ; De Hui ZHANG ; Xue Wen SU ; Zheng Hai QU ; Ying ZHANG ; Shi Yong ZHAO ; Zheng Hong QI ; Lin PANG ; Cai Ying WANG ; Hui Ling DENG ; Xing Lou LIU ; Ying Hu CHEN ; Sainan SHU
Chinese Journal of Pediatrics 2022;60(10):1045-1053
Objective: To analyze the clinical epidemiological characteristics including composition of pathogens , clinical characteristics, and disease prognosis acute bacterial meningitis (ABM) in Chinese children. Methods: A retrospective analysis was performed on the clinical and laboratory data of 1 610 children <15 years of age with ABM in 33 tertiary hospitals in China from January 2019 to December 2020. Patients were divided into different groups according to age,<28 days group, 28 days to <3 months group, 3 months to <1 year group, 1-<5 years of age group, 5-<15 years of age group; etiology confirmed group and clinically diagnosed group according to etiology diagnosis. Non-numeric variables were analyzed with the Chi-square test or Fisher's exact test, while non-normal distrituction numeric variables were compared with nonparametric test. Results: Among 1 610 children with ABM, 955 were male and 650 were female (5 cases were not provided with gender information), and the age of onset was 1.5 (0.5, 5.5) months. There were 588 cases age from <28 days, 462 cases age from 28 days to <3 months, 302 cases age from 3 months to <1 year of age group, 156 cases in the 1-<5 years of age and 101 cases in the 5-<15 years of age. The detection rates were 38.8% (95/245) and 31.5% (70/222) of Escherichia coli and 27.8% (68/245) and 35.1% (78/222) of Streptococcus agalactiae in infants younger than 28 days of age and 28 days to 3 months of age; the detection rates of Streptococcus pneumonia, Escherichia coli, and Streptococcus agalactiae were 34.3% (61/178), 14.0% (25/178) and 13.5% (24/178) in the 3 months of age to <1 year of age group; the dominant pathogens were Streptococcus pneumoniae and the detection rate were 67.9% (74/109) and 44.4% (16/36) in the 1-<5 years of age and 5-<15 years of age . There were 9.7% (19/195) strains of Escherichia coli producing ultra-broad-spectrum β-lactamases. The positive rates of cerebrospinal fluid (CSF) culture and blood culture were 32.2% (515/1 598) and 25.0% (400/1 598), while 38.2% (126/330)and 25.3% (21/83) in CSF metagenomics next generation sequencing and Streptococcus pneumoniae antigen detection. There were 4.3% (32/790) cases of which CSF white blood cell counts were normal in etiology confirmed group. Among 1 610 children with ABM, main intracranial imaging complications were subdural effusion and (or) empyema in 349 cases (21.7%), hydrocephalus in 233 cases (14.5%), brain abscess in 178 cases (11.1%), and other cerebrovascular diseases, including encephalomalacia, cerebral infarction, and encephalatrophy, in 174 cases (10.8%). Among the 166 cases (10.3%) with unfavorable outcome, 32 cases (2.0%) died among whom 24 cases died before 1 year of age, and 37 cases (2.3%) had recurrence among whom 25 cases had recurrence within 3 weeks. The incidences of subdural effusion and (or) empyema, brain abscess and ependymitis in the etiology confirmed group were significantly higher than those in the clinically diagnosed group (26.2% (207/790) vs. 17.3% (142/820), 13.0% (103/790) vs. 9.1% (75/820), 4.6% (36/790) vs. 2.7% (22/820), χ2=18.71, 6.20, 4.07, all P<0.05), but there was no significant difference in the unfavorable outcomes, mortility, and recurrence between these 2 groups (all P>0.05). Conclusions: The onset age of ABM in children is usually within 1 year of age, especially <3 months. The common pathogens in infants <3 months of age are Escherichia coli and Streptococcus agalactiae, and the dominant pathogen in infant ≥3 months is Streptococcus pneumoniae. Subdural effusion and (or) empyema and hydrocephalus are common complications. ABM should not be excluded even if CSF white blood cell counts is within normal range. Standardized bacteriological examination should be paid more attention to increase the pathogenic detection rate. Non-culture CSF detection methods may facilitate the pathogenic diagnosis.
Adolescent
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Brain Abscess
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Child
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Child, Preschool
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Escherichia coli
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Female
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Humans
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Hydrocephalus
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Infant
;
Infant, Newborn
;
Male
;
Meningitis, Bacterial/epidemiology*
;
Retrospective Studies
;
Streptococcus agalactiae
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Streptococcus pneumoniae
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Subdural Effusion
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beta-Lactamases
4.Dual artificial intelligence-assisted diagnosis and treatment for patients with multiple primary lung cancer
Rongqiang CAI ; Kaize ZHONG ; Jikuan LIU ; Xin LI ; Baoxiang PEI ; Kang ZHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(05):510-513
Objective To explore the value of artificial intelligence (AI) diagnostic imaging system and three dimensional computed tomographic bronchoangiography (3D-CTBA) surgical planning system in the management of multiple primary lung cancer (MPLC). Methods The clinical data of 53 patients with MPLC treated surgically in our hospital from January 2018 to August 2020 were retrospectively analyzed, including 16 males and 37 females, with a median age of 60 (39-75) years. The patients' preoperative CT was analyzed by AI and manually, and the data of patients who underwent 3D-CTBA were compiled to evaluate the value of AI and 3D-CTBA in the diagnosis and treatment of MPLC, respectively. Results The sensitivity of AI screening for MPLC was 84.91%. The sensitivity (91.90% vs. 83.78%) and accuracy (85.60% vs. 84.00%) of AI diagnosis of high-risk MPLC infiltrative lesions were better than those of manual diagnosis. 3D-CTBA was used for planning the surgery in 12 patients, and the intraoperative situation was generally consistent with the reconstructed results. Conclusion AI is of high value in identifying infiltrative lesions of MPLC. 3D-CTBA reconstruction of anatomical structures is accurate and can guide preoperative planning.
5.Risk Factors for Duodenal Stump Leakage after Laparoscopic Gastrectomy for Gastric Cancer
Lihu GU ; Kang ZHANG ; Zefeng SHEN ; Xianfa WANG ; Hepan ZHU ; Junhai PAN ; Xin ZHONG ; Parikshit Asutosh KHADAROO ; Ping CHEN
Journal of Gastric Cancer 2020;20(1):81-94
PURPOSE:
Duodenal stump leakage (DSL) is a potentially fatal complication that can occur after gastrectomy, but its underlying risk factors are unclear. This study aimed to investigate the risk factors and management of DSL after laparoscopic radical gastrectomy for gastric cancer (GC).
MATERIALS AND METHODS:
Relevant data were collected from several prospective databases to retrospectively analyze the data of GC patients who underwent Billroth II (B-II) or Roux-en-Y (R-Y) reconstruction after laparoscopic gastrectomy from 2 institutions (Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and HwaMei Hospital, University of Chinese Academy of Sciences). The DSL risk factors were analyzed using univariate and multivariate analysis regression.
RESULTS:
A total of 810 patients were eligible for our analysis (426 with R-Y, 384 with B-II with Braun). Eleven patients had DSL (1.36%). Body mass index (BMI), elevated preoperative C-reactive protein (CRP) level, and unreinforced duodenal stump were the independent risk factors for DSL. DSL was diagnosed in 2–12 days, with a median of 8 days. Seven patients received conservative treatment, 3 patients received puncture treatment, and only 1 patient required reoperation. All patients recovered successfully after treatment.
CONCLUSIONS
The risk factors of DSL were BMI ≥24 kg/m², elevated preoperative CRP level, and unreinforced duodenal stump. Nonsurgical treatments for DSL are preferred.
6.Analysis of species distribution and antibiotic susceptibility trends of 1.172 bacterial uropathogens isolated in urine cultures on an outpatient basis
Dihua ZHANG ; Kang LIAO ; Xiaoqing ZHONG ; Xin WANG ; Yagui QIU ; Xunhua ZHENG ; Jianbo LI ; Yuanwen XU ; Guangran LI ; Xiao YANG ; Fengxian HUANG
Chinese Journal of Nephrology 2020;36(7):519-525
Objective:To assess the bacterial profiles and antimicrobial susceptibility patterns in uropathogens, and help to inform the empiric treatment decisions for urinary tract infection in outpatient settings.Methods:A single institutional retrospective analysis was performed on positive urine cultures from outpatient settings between January 1998 and December 2018. To analyze changes over time, trends analysis were undertaken on bacterial profiles, antimicrobial susceptibility and resistance.Results:A total of 1.172 pathogenic bacteria were isolated after exclusion of duplicate strains originated from the same patient, including 991(84.6%) Gram-negative bacterial strains and 181(15.4%) Gram-positive strains. The most common Gram-negative uropathogens were Escherichia coli (60.8%) and Klebsiella pneumonia (8.1%). Enterococcus faecalis (4.6%) was the predominant Gram-positive strain. The detection rate of Escherichia coli increased significantly, from 50.8% to 63.2% ( χ2=7.978, P=0.046), and no significant difference was observed in the distribution of major uropathogenic bacteria over the 20 years (all P>0.05). The proportion of extended-spectrum β-lactamase (ESBLs) producing strains increased significantly across the 20 years ( P<0.05). The resistance rates of Escherichia coli to amoxicillin and clavulanate potassium, aztreonam, ceftazidime, ciprofloxacin and sulbactam + cefoperazone increased significantly (all P<0.05). All the isolates sustained high susceptibility to tazobactam + piperacillin, amikacin, imipenem and nitrofurantoin (95.0%, 95.7%, 97.9% and 91.1%). Similar to those of Escherichia coli, Klebsiella pneumoniae remained a high and stable sensitivity to tazobactam+piperacillin, amikacin and imipenem during the 20 years (79.1%, 88.0% and 80.3%). However, the proportion of ESBLs producing strains increased significantly ( P<0.05). Among Gram-positive bacteria isolates, the sensitivity rates of Enterococcus faecalis to ampicillin, nitrofurantoin and penicillin G were 100.0%. No vancomycin resistant strain was detected in Gram-positive bacteria. Conclusions:From 1998 to 2018, Escherichia coli and Klebsiella pneumoniae are the most common Gram-negative bacteria uropathogens obtained in outpatient settings. Significant increases of resistance to some antimicrobial agents such as second- and third-generation cephalosporins and fluoroquinolones are observed during the 20 years and high susceptibilities to tazobactam+piperacillin, amikacin, imipenem and nitrofurantoin sustain over time. Local treatment strategies of urinary tract infections on outpatient basis should be made according to epidemiology of drug resistance and individual characteristics to control the spread and curb the prevalence of drug resistant.
7. Differentiation of hypovascular pancreatic neuroendocrine tumors and mass-forming pancreatitis by enhanced CT
Ya-jie WANG ; Xiao CHEN ; Xin CHEN ; Can CUI ; Yong-kang LIU ; Hao ZHOU ; Zhong-qiu WANG
Journal of Medical Postgraduates 2020;33(7):732-736
ObjectiveTo explore the value of MSCT for differentiating the hypovascular pancreatic neuroendocrine tumors (Hypo-PNETs) from mass-forming pancreatitis.Methods21 patients with histological-confirmed MPFs and 19 patients with Hypo-PNETs who underwent preoperative dynamic contrast-enhanced CT were included. The CT images were analyzed including tumor size,density, border, CT values in each phase, dilatation of pancreatic duct and bile duct and metastases. The clinical data included age, sex and clinical symptoms.ResultsMFPs often occurred in male patient compared with Hypo-PNETs (85.7% vs 52.6%, P<0.05), and the difference is statistically significant; Metastases only occurred in Hypo-PNETs (P<0.05), and the difference is drastically significant. The well-defined margin often occurred in Hypo-PNETs (52.4% vs 47.6%, P=0.032). Solid tumor more happened in MFPs(95.2% vs 47.4%, P<0.05). The CT values in the portal of MFPs were higher than Hypo-PNETs(P<0.05). The combined features showed accepted diagnostic performance for differentiating Hypo-PNETs from MFPs (89.5% of sensitivity and 95.2% of specificity).ConclusionMFPs often occurred in male patient, and CT values of portal phase, density, border and metastases may be valuable for differentiating Hypo-PNETs from MFPs.
8. Rehepatectomy and radiofrequency ablation for patients with recurrent hepatocellular carcinoma
Kang CHEN ; Xin-yu LIU ; Xu-xian TENG ; Jian-hong ZHONG ; Le-qun LI
Chinese Journal of Practical Surgery 2019;39(10):1060-1064
OBJECTIVE: To observe the safety and efficacy of rehepatectomy and radiofrequency ablation for patientswith recurrent hepatocellular carcinoma(HCC).METHODS: A consecutive sample of 159 recurrent HCC patients whounderwent rehepatectomy(n=77) or radiofrequency ablation(n=82) from January 2005 to December 2014 were analyzedretrospectively. Propensity score analysis was used. The Kaplan-Meier method was used for survival analysis.RESULTS: Propensity score analysis chose 41 pair patients. Patients in the radiofrequency ablation group were with lower rate ofperioperative mortality and morbidiy,shorter length of hospital stay. When calculate the survival time from the date ofrehepatectomy or radiofrequency ablation,or calculate the survival time from the date of the first hepatectomy,the twoarms showed similar overall survival(P=0.258,0.820). Moreover,overall survival were similar after propensity scoreanalysis(P=0.443,0.917).CONCLUSION: Radiofrequency ablation was safety,associated with shorter length of hospitalstay and similar long-term overall survival with rehepatectomy for recurrent HCC.
9. Features and therapeutic potential of T-cell receptors in high-grade glioma
Jie-Lin ZHANG ; Xiao-Song ZHONG ; Shou-Bo YANG ; Xun KANG ; Yan LI ; Jian-Xin CHEN ; Wen-Bin LI
Chinese Medical Journal 2019;132(12):1435-1440
Background:
Previous studies have shown that endogenous T cells play an important role in the prolonged survival time of highgrade glioma (HGG) patients. Our objectives were to investigate the features of T-cell receptor (TCR) repertoires in HGG patients and to elucidate any potential therapeutic value.
Methods:
During November 2011 and December 2018, tumor tissues and blood samples of 35 patients with HGG who underwent surgery at Beijing Tiantan Hospital or Beijing Shijitan Hospital were selected after surgery. After isolating DNA from samples, multiple rounds of PCR were performed to establish a DNA immune repertoire (IR). Then, the sequences and frequencies of the complementarity-determining 3 (CDR3) region in TCR beta chain (TRB) were identified by high-throughput sequencing and IR analysis. A survival follow-up was conducted monthly thereafter until December 2018. Finally, the
10.The role of tumor size, ultrasonographic findings, and serum tumor markers in predicting the likelihood of malignant testicular histology.
Gang SONG ; Geng-Yan XIONG ; Yu FAN ; Cong HUANG ; Yong-Ming KANG ; Guang-Jie JI ; Jin-Chao CHEN ; Zhong-Cheng XIN ; Li-Qun ZHOU
Asian Journal of Andrology 2019;21(2):196-200
The clinical predictive factors for malignant testicular histology remain unclear because of the low prevalence. Therefore, the aim of this study was to investigate predictors of malignant histology for testicular masses and decide more testis-sparing surgeries before surgery. This retrospective study enrolled 325 consecutive testicular mass patients who underwent radical orchiectomy (310/325) or testicular preserving surgery (15/325) from January 2001 to June 2016. The clinicopathological factors, including tumor diameter, cryptorchidism history, ultrasound findings, serum alpha-fetoprotein, and human chorionic gonadotropin (HCG) levels, were collected retrospectively for statistical analysis. A predictive nomogram was also generated to evaluate the quantitative probability. Among all patients, 247 (76.0%) were diagnosed with a malignant testicular tumor and 78 (24.0%) with benign histology. Larger tumor diameter (per cm increased, hazard ratio [HR] = 1.284, P = 0.036), lower ultrasound echo (HR = 3.191, P = 0.001), higher ultrasound blood flow (HR = 3.320, P < 0.001), and abnormal blood HCG (HR = 10.550, P < 0.001) were significant predictive factors for malignant disease in all testicular mass patients. The nomogram generated was well calibrated for all predictions of malignant probability, and the accuracy of the model nomogram measured by Harrell's C statistic (C-index) was 0.92. According to our data, the proportion of patients who underwent radical orchiectomy for benign tumors (24.0%) was much larger than generally believed (10.0%). Our results indicated that the diameter, ultrasonic echo, ultrasonic blood flow, and serum HCG levels could predict the malignancy in testicular mass patients.
Adolescent
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Adult
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Aged
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Aged, 80 and over
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Biomarkers, Tumor/blood*
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Child
;
Chorionic Gonadotropin/blood*
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Humans
;
Male
;
Middle Aged
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Orchiectomy
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Prognosis
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Retrospective Studies
;
Testicular Neoplasms/surgery*
;
Testis/pathology*
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Tumor Burden
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Ultrasonography
;
Young Adult
;
alpha-Fetoproteins/metabolism*

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